背景:在美国,新型紫外线过滤器的可用性落后于欧盟(EU),部分原因是不同的审批流程。
目的:审查所有美国和欧盟批准的紫外线过滤剂的可用人体安全性数据。
方法:来自食品和药物管理局和欧盟监管指南的数据,联邦政府文件,数据库,reviews,并对审批意见和正在进行的安全评价进行了分析。
结果:目前,有17个美国紫外线过滤器和29个欧盟紫外线过滤器(18个欧盟批准的过滤器)。几乎所有美国过滤器都拥有敏感数据(94%,16/17),多数(76%,13/17)显示最小的皮肤致敏。欧盟批准的少数过滤器(33%,6/18)拥有敏感化数据,都没有表现出敏感。一些过滤器具有皮肤吸收数据(美国:76%,13/17;欧盟:44%,8/18).氧苯酮,octinoxate,八盐,同盐酸盐,和辛炔,在美国和欧盟批准,显示血浆水平超过食品和药物管理局的暴露阈值。
结论:没有专有制造商的人类数据。
结论:欧盟有许多新的紫外线过滤剂,但在美国还没有。严格的美国和欧盟指南确保紫外线过滤器提供足够的光保护,假设消费者遵循美国皮肤病学会SPF(防晒系数)和广谱建议。人类数据有限,但是已知人类使用防晒霜的风险似乎很小。
BACKGROUND: Availability of new UV filters in the United States lags behind the European Union (EU), partly due to differing approval processes.
OBJECTIVE: To
review available human safety data of all US- and EU-approved UV filters.
METHODS: Data from Food and Drug Administration and EU regulatory guidelines, federal governmental documentation, databases, reviews, and opinions for approval and ongoing safety evaluation were analyzed.
RESULTS: Currently, there are 17 US UV filters and 29 EU UV filters (18 EU-approved only filters). Almost all US filters possessed sensitization data (94%, 16/17) with the majority (76%, 13/17) showing minimal skin sensitization. The minority of EU-approved only filters (33%, 6/18) possessed sensitization data, all showing no sensitization. Some filters possessed dermal absorption data (US: 76%, 13/17; EU: 44%, 8/18). Oxybenzone, octinoxate, octisalate, homosalate, and octocrylene, approved in the US and EU, were shown to have plasma levels exceeding the Food and Drug Administration exposure threshold.
CONCLUSIONS: Proprietary manufacturer human data were unavailable.
CONCLUSIONS: Many new UV filters are available in the EU, but not yet in the United States. Rigorous US and EU guidelines ensure that UV filters provide adequate photoprotection assuming consumers follow American Academy of Dermatology SPF (sun protection factor) and broad-spectrum recommendations. Human data are limited, but known human risks of sunscreen appear minimal.